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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02230540
Other study ID # CP250
Secondary ID
Status Terminated
Phase N/A
First received August 28, 2014
Last updated February 17, 2016
Start date September 2014
Est. completion date September 2014

Study information

Verified date February 2016
Source Coloplast A/S
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Has given written informed consent

- Is at least 18 years of age and has full legal capacity

- Is a male

- Has an Spinal Cord Injury diagnosis

Exclusion Criteria:

- Participating in other interventional clinical investigations or have previously participated in this investigation

- Known hypersensitivity toward any of the test products

- Serious abdominal scars

- Symptoms of urinary tract infections

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Device:
SelfCath (comparator)
Commercially available CE-marked catheter for urinary drainage.
Product A SelfCath and urine bag, Conveen Security+
SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
Product B SelfCath and urine bag, Conveen Contour
SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).

Locations

Country Name City State
Denmark Per Bagi Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Coloplast A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Residual Volume Less Than 100ml The primary endpoint was "Residual volume less than 100 ml (Yes/No)" assessed after catheterization when placed at fixed heights (25, 20, 15, 10 and 0 cm) over the wheelchair seat.
Prior to the catheterization corresponding to height 25 cm, a solution was instilled into the bladder to ensure a volume equal to 300 ml. The residual volume at height 25 cm was then calculated as 300 ml minus the volume emptied during catheterization. The residual volume corresponding to height 20 cm was calculated as the residual volume corresponding to height 25 minus the additional volume emptied at height 20. The residual volume corresponding to height 15, 10 and 0 cm were derived similarly.
Calculated residual volumes were negative, likely due to faulty ultrasound scans performed on subjects in sitting position. Consequently, the changes in bladder volumes, re-worded from "300ml - collected volume <100ml" to "collected volume > 200ml", were used to interpret the primary endpoint.
2-4 hours No
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